Symptomatic relief of chronic, intractable pain
Symptomatic relief of acute pain
As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

Device Description

The BioWaveGO Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain the technology of parent devices BioWavePRO. The key difference between the BioWaveGO and the parent device, the BioWaveHOME, is a reduced maximum voltage level, making the device available over-the-counter. The BioWaveGO device has a smaller battery system compared to the BioWaveGO device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain.

AI/ML Overview

The provided text describes the BioWaveGO Neuromodulation Pain Therapy Device, its indications for use, and a comparison with predicate devices to establish substantial equivalence for FDA clearance. However, it does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on regulatory clearance through substantial equivalence, which compares a new device to existing legally marketed predicate devices, rather than an independent performance study with defined acceptance criteria and statistical analysis.

Therefore, the requested information cannot be fully extracted from the provided text. I will detail what can be inferred or is explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum pain reduction, specific accuracy metrics). Instead, it focuses on functional and electrical safety compliance.

Acceptance Criteria (Inferred from Performance Testing Summary)	Reported Device Performance (Summary of Testing)
Session timer operational only during active treatment	Confirmed
Charging only when device not in use	Confirmed
Active treatment sessions cannot start during charging	Confirmed
Consistent operation across various intensities and load impedances	Ensured
Recognition of cable and electrodes before and during session	Ensured
Detection of invalid load impedances before and during session	Ensured
Resistance to damage/improper software operation from abuse of charger ports	Determined (no damage/improper operation)
Inherent protection from excessive battery drain in over-temperature situations	Determined (device protects against abnormal draw)
Functional hardware watchdog timers for device reset	Determined (functional)
Evaluation of electrical safety	Concluded as compliant (implied by clearance)
Compliance with 21 CFR 898	Yes
Compliance with Voluntary Standards	Yes

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The "Performance Testing Summary" outlines a list of tests conducted, but it does not specify the sample size of devices tested or any patient data provenance. The clearance is based on comparison to predicates and engineering/safety testing, not clinical performance data in patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document describes technical performance testing and safety evaluations, not a study that would require expert-established ground truth related to clinical outcomes or image interpretation.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical or interpretive "ground truth" establishment by experts is mentioned, an adjudication method is not applicable to the described engineering and safety tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in this document. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the BioWaveGO device. It is a physical medical device providing electrical stimulation, not an algorithm, and it is intended for human use, either over-the-counter or with a prescription (for its predicate).

7. The Type of Ground Truth Used

The "ground truth" for the tests described appears to be based on engineering specifications, safety standards, and functional requirements of the device. For example, ensuring the session timer is operational only during active treatment means verifying the device's software behaves according to its design specification under various conditions. There is no mention of pathology, expert consensus on clinical findings, or outcomes data being used as ground truth for the technical tests performed.

8. The Sample Size for the Training Set

This information is not provided. Since this is a hardware device cleared based on substantial equivalence and engineering tests, rather than an AI/ML algorithm or a device requiring a clinical efficacy trial with a training set, this concept is not applicable in the context described.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no mention of a training set for an algorithm or a device requiring such.

Summary

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Image /page/0/Picture/0 description: The image shows the date August 17, 2018. The text is in a simple, sans-serif font and is horizontally aligned. The date is written out in full, with the month, day, and year clearly visible.

Biowave Corporation % Dave Mcgurl Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001

Re: K180943

Trade/Device Name: BioWaveGO Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, GZJ Dated: July 11, 2018 Received: July 11, 2018

Dear Dave McGurl:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carlos L. Pena -S) A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180943

Device Name BioWaveGo

Indications for Use (Describe)

The BioWaveGO Neuromodulation Pain Therapy Device is indicated for:

Symptomatic relief of chronic, intractable pain
Symptomatic relief of acute pain
As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

K180943

Device Trade Name:	BioWaveGO System
Manufacturer:	BioWave Corporation8 Knight Street, Suite 201Norwalk, CT 06851
Contact:	Bradford SiffFounder & PresidentBioWave Corporation8 Knight Street, Suite 201Norwalk, CT 06851Phone: 203-635-7175Fax: 203-286-2518brad.siff@biowave.com
Prepared by:	Mr. Dave McGurlDirector, Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Office: 202.552.5797Fax: 202.552.5798dmcgurl@mcra.com
Date Prepared:	April 26th, 2018
Classifications:	21 CFR §882.5890, Transcutaneous electrical nerve stimulator for pain relief

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Class: II

Product Codes: NUH, GZJ

Indications For Use:

The BioWaveGO Neuromodulation Pain Therapy is indicated for:

· Symptomatic relief of chronic, intractable pain
Symptomatic relief of acute pain
As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

Device Description:

Predicate Device:

The Bio Wave Corporation's Bio WaveGO Neuromodulation Pain Therapy Device is substantially equivalent to the previously cleared with respect to indications, design, function, and materials, as outlined below.

Manufacturer	Device Name	K-Number
BioWave Corporation(primary predicate)	BioWaveHOME	K152437
NeuroMetrix, Inc.(reference device)	Quell	K152954
Fuji Dynamics Ltd.(reference device)	LL TENS 160A, LL TENS 160B	K152374

Performance Testing Summary:

The testing of the BioWaveGO device and the smartphone app includes:

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· Testing of basic operational modes to confirm that the session timer is only operational during active treatment time.
· Battery testing to ensure charging only occurs when the device is not in use and that active treatment sessions cannot be started during charging.
Testing to ensure consistent operation across various intensities and load impedances. .
Testing to ensure recognition of the cable and electrodes before and during an active session. .
Testing to ensure invalid load impendences are detected before and during an active session. ●
Abuse of the battery charger input and output ports testing to determine if damage to the device or improper software operation occurs.
· Testing in over-temperature situations to determine if the inherent protect draw on the battery outside safe operating temperatures.
· Testing to determine if the hardware watchdog timers were functional at resetting the device.
Evaluation of electrical safety. .

Predicate Comparison Table
	Subject DeviceBioWaveGO Device	Predicate DeviceBioWaveHOME Device	Reference DeviceQuell
Manufacturer	BioWave Corporation	BioWave Corporation	Neurometrix, Inc.
Trade Name	BioWaveGO	BioWaveHOME	Quell
510(k)	K180943	K152437	K152954
Bluetooth Capable	Yes	No	Yes
SmartphoneInterface	Yes	No	Yes
Prescription orOver-the-Counter	Over-the-Counter	Prescription	Over-the-Counter

Substantial Equivalence:

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	Subject Device	Predicate Device	Reference Device
	BioWaveGO Device	BioWaveHOME Device	Quell
Image	Image: BioWaveGO Device	Image: BioWaveHOME Device	Image: Quell
Indications	The BioWaveGO Neuromodulation PainTherapy Device is indicated for:- Symptomatic relief of chronic,intractable pain, post-surgical, and post-traumatic acute pain- Symptomatic relief of acute pain- Symptomatic relief of post-operativepain	The BioWaveHOME NeuromodulationPain Therapy Device is indicated for:- Symptomatic relief of chronic,intractable pain, post-surgical, and post-traumatic acute pain- Symptomatic relief of acute pain- Symptomatic relief of post-operativepain	Quell is intended for use as atranscutaneous electrical nervestimulation device for the symptomaticrelief and management of chronicintractable pain.The device may be used during sleep. Thedevice is labeled for use only withcompatible NeuroMetrix electrodes.
	BioWave CorporationBioWaveGO Device	BioWave CorporationBioWaveHOME Device	Comparison of BioWaveGO andBioWaveHOME
510(k) Number	K180943	K152437	-
Device Name, Model	BioWaveGO	BioWaveHOME	-
Manufacturer	BioWave Corporation	BioWave Corporation	Identical
Availability	Over-the-Counter	Prescription	BioWaveGO is designed as an over-the-counter neuromodulation pain therapy devicesharing identical specifications to the parentdevice, BioWaveHOME, with the exceptionof a decreased maximum voltage (20V versus27.5V)
Power Source(s)	one 3.2V 1100mAh rechargeablelithium iron phosphate battery	two 3.2V 3300mAh rechargeablelithium iron phosphate batteries	Similar power source but a smaller batterysystem in BioWaveGO vs BioWaveHOME
Method of Line Current Isolation	Battery + interlocks	Battery + interlocks	Identical
Patient Leakage Current	None	None	Identical
Normal condition	None	None	Identical
Single fault condition	None	None	Identical
Number of Output Modes	One	One	Identical
Number of Output Channels	One	One	Identical
Synchronous or Alternating?	N/A	N/A	-
Method of Channel Isolation	N/A	N/A	-
Regulated Current or RegulatedVoltage?	Regulated Voltage	Regulated Voltage	Identical
Software/Firmware/MicroprocessorControl?	Yes	Yes	Identical
Automatic Overload Trip?	Yes (software)	Yes (software)	Identical
Automatic No-Load Trip?	Yes (software)	Yes (software)	Identical
Automatic Shut Off?	Yes	Yes	Identical
Patient Override Control?	Yes	Yes	Identical
Indicator Display:	Yes	Yes	Identical
On/Off Status?	Yes	Yes	Identical
Low Battery?	Yes	Yes	Identical
Voltage/Current Level?	Yes (% of full scale)	Yes (% of full scale)	Identical
Timer Range - (minutes)	30	30	Identical
Compliance with VoluntaryStandards?	Yes	Yes	Identical
	BioWave CorporationBioWaveGO Device	BioWave CorporationBioWaveHOME Device	Comparison of BioWaveGO andBioWaveHOME
Compliance with 21 CFR 898?	Yes	Yes	Identical
Weight	6 ounces	1.0 lbs	BioWaveGO is lighter
Dimensions (in.) (W x H x D)	3.0" x 4.0" x 1.0"	3.75" x 6.0" x 1.75"	BioWaveGO is smaller
Housing Materials and Construction	ABS via conventional injectionmolding	ABS via conventional injectionmolding	Identical

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Comparison of Basic Unit Characteristics for BioWaveHOME and BioWaveGO

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Comparison of Output Specifications for BioWaveHOME and BioWaveGO

	BioWave CorporationBioWaveGO Device	Parent BioWave CorporationBioWaveHOME Device	Comparison of BioWaveGO andBioWaveHOME
Waveform	Biphasic	Biphasic	Identical
Shape	Sum of 2 sine waves	Sum of 2 sine waves	Identical
Maximum Output VoltageAvailable(+1-2%) (with softwarecalibration correction)	80V p-p @ 500 Ω20 V AC RMS	110V p-p @ 500 Ω27.5 V AC RMS	BioWaveGO offers a decreased maximumvoltage to allow for over-the-counteravailability. The decrease in voltage does notimpact safety or performance of the device.
Maximum Output Current(+1- 2 %)(current depends on load)	160mA p-p @ 500 Ω40mA RMS40 mA p-p @ 2kΩTrip out @ 10kΩ	220mA p-p @ 500 Ω55mA RMS55 mA p-p @ 2kΩTrip out @ 10kΩ	BioWaveGO has a lower maximum currentdensity.
Pulse Width	Continuous modulation	Continuous modulation	Identical
For multiphasic waveforms only:- Symmetrical phases?- Phase Duration	N/AN/A	N/AN/A	-
Net Charge (m C per pulse) (If zero,state method of achieving zero netcharge.)	0 @ 500 Ωbiphasic – AC coupled continuouswave	0 @ 500 Ωbiphasic – AC coupled continuouswave	Identical
Maximum Phase Charge, (μ C)	N/A	N/A	-
Maximum Current Density,(µmA/cm²) (with 1.375" diam pad =9.58 cm2 area)	6.9 ma rms per cm² @ 500 Ω	6.9 ma rms per cm² @ 500 Ω	Identical
Maximum Power Density, (W/cm²)(using 1.375" diam 9.58 cm² electrodeconductive surface area)	0.19 W rms per cm² @ 500 Ω	0.19 W rms per cm² @ 500 Ω	Identical
Burst Modea. Pulses per burstb. Bursts per secondc. Burst duration (seconds)	N/A	N/A	-

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	BioWave Corporation	Parent BioWave Corporation	Comparison of BioWaveGO and
	BioWaveGO Device	BioWaveHOME Device	BioWaveHOME
d. Duty Cycle [Line (b) x Line (c)]
ON Time (seconds)	N/A	N/A	-
OFF Time (seconds)	N/A	N/A	-
Additional Features (if applicable)	Many safety interlocks: cableconnected to unit, pads connected tocable, pads connected to body, maxpower density, battery ok fortreatment, charger connected (tripoff)	Many safety interlocks: cableconnected to unit, pads connected tocable, pads connected to body, maxpower density, battery ok fortreatment, charger connected (tripoff)	Identical

The subject device, the BioWaveGO, was demonstrated to be substantially equivalent to predicate device K152437 cited in the table above with respect to design, materials, function, manufacturing, and to the reference devices (K152374 and K152954) with respect to IFU and over-the-counter use.

Conclusion:

The BioWaveGO device has been found to be substantially equivalent to the previously cleared predicate device, BioWaveHOME (K152437), with respect to its design, function, materials, and the reference devices, LL TENS 160A, LL TENS 160B (K152374) and Quell (K152954) with respect to indications for use and over-the-counter availability.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).